Some Children's Swine Flu Vaccines Recalled

< Dec. 16, 2009 > -- The Centers for Disease Control and Prevention (CDC) announced this week that over three-quarters of a million doses of H1N1 flu vaccine for children have been recalled by the manufacturer due to a loss in potency.

According to the CDC, the routine testing of the vaccine for children aged 6 months to almost 3 years found that four batches had lower than required potency levels. "This means that doses from these four vaccine lots no longer meet the manufacturer's specifications for potency," according to the CDC.

The manufacturer of the vaccine in question is Sanofi Pasteur Inc.

"This is not a safety problem; it's an issue of efficacy," says infectious disease expert Dr. Marc Siegel, an associate professor of medicine at New York University, in New York City.

Recall Indicates Testing Being Done

Dr. Siegel says this recall is good news because it means the vaccine is being tested after it is shipped. "I am happy to see them testing this, because one of the things that happens is once a vaccine gets to market it kind of gets forgotten," he says.

The doses being recalled are in single dose pre-filled syringes, and do not contain the preservative thimerosal. To be protected from swine flu, children under 10 need two shots spaced about a month apart.

"I don't think this is a coincidence that this is occurring in the single-dose syringes," Dr. Siegel says. "This process is very labor-intensive. The more intensive the process, the more likely we will see variation in efficacy."

Vaccine is Still Safe to Use

Although the manufacturer is asking that unused doses be returned, the vaccine itself is safe. "There are no safety concerns with these lots of H1N1 vaccine. All lots successfully passed pre-release testing for purity, potency and safety," the CDC says.

Since the potency of the recalled vaccine is only "slightly" below the required range of potency, children who have received vaccine from these lots do not need to be revaccinated.

Dr. Siegel agrees that the small drop in potency is not enough to require another vaccination. "The children that received this vaccine are very likely to have a significant amount of immunity, because the immune response as tested in studies was profound," he says.

Other Formulations Okay

The CDC points out that for children aged 6 months and older, vaccine in multi-dose vials is available. Vaccine in multi-dose vials has not had this drop in potency and "meets all standards of safety, purity and potency."

Like all multi-dose vials of vaccines, these vials contain thimerosal to prevent contamination after the vial is opened. The standard dose from these vials is the same as for the pre-filled syringes.

In addition, for children aged 2 and older, the H1N1 vaccine is also available as a nasal spray called FluMist.

Since early October, about 95 million doses of swine flu vaccine have been distributed in the United States.

Always consult your child's physician for more information.

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The Importance of Immunizations

Immunization is key to preventing disease among the general population. Vaccines benefit both the people who receive them, and the vulnerable, unvaccinated people around them, because the infection can no longer spread. In addition, immunizations reduce the number of deaths and disability from infections, such as whooping cough and chickenpox.

Although children receive the majority of the vaccinations, adults also need to stay up-to-date on certain vaccinations, including tetanus and diphtheria. In addition, those adults who have never had chickenpox or measles during childhood (nor the vaccines against these specific diseases) should consider being vaccinated. Childhood illnesses such as mumps, measles, and chickenpox can cause serious complications in adults.

Many childhood diseases can now be prevented by following recommended guidelines for vaccinations:

MMR - to protect against measles, mumps and rubella (German measles).
Pneumococcal vaccine - to protect against pneumonia, infection in the blood, and meningitis.

Varicella - to protect against chickenpox.

RotaTeq® - to prevent rotavirus gastroenteritis in infants.

Hep A - to prevent viral infection of the liver.

HPV - to protect females from human papillomavirus, which is linked to cervical cancer.

A child's first vaccination is given at birth. Immunizations are scheduled throughout childhood, with many beginning within the first few months of life. By following a regular schedule, and making sure a child is immunized at the right time, you are ensuring the best defense against dangerous childhood diseases.

As with any medication, vaccinations may cause reactions, usually in the form of a sore arm or low-grade fever. Although serious reactions are rare, they can happen, and your child's physician or nurse may discuss these with you before giving the shots. However, the risks of contracting the diseases the immunizations provide protection from are higher than the risks of having a reaction to the vaccine.